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Guidelines for sterility testing of therapeutic goods

13 September 2006

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3. Precautions against microbial contamination

300. Relevant section of the BP/Ph Eur: 'Precautions against microbial contamination'

301. Tests for sterility are to be carried out by trained personnel using techniques and equipment which minimise the risks of accidental microbial contamination of the tests and of the testing environment.

302. Tests for sterility should be conducted in a clean-room environment that is equivalent to the standard of clean-room required for the aseptic manufacture of pharmaceutical products. Additional guidance is given in Annex IV.

303. Personnel occupying the aseptic testing area during sterility testing or associated aseptic manipulations should wear sterilised overgarments. The use of sanitised garments may be acceptable under certain conditions (see Annex IV).

304. All equipment, vessels and materials with which the sterile test media or the goods under test may come into contact in the course of the testing should be sterilised prior to use. Preferred methods are heating in an autoclave so that all surfaces are held at a temperature of 121°C and exposed to saturated steam for at least 15 minutes, or by heating to, and holding for at least 2 hours at a temperature of 160°C in a hot air oven, or by exposure to a minimum absorbed radiation dose of 25 kGy.

305. All substances added to the goods tested, and all substances added to sterile media or introduced into sterile membrane filtration units (other than the preparations under test) should be sterilised prior to use by heat. If this reduces the effectiveness of the test the most effective alternative method should be used.

306. Prior to sterilisation, all vessels, substances or outer clothing to be used for the performance of tests for sterility, or introduced into the testing area, should be appropriately packaged or closed, so as to prevent access of micro-organisms. Each package or item being sterilised should bear a visual indicator appropriate to the method of sterilisation to indicate that it has been processed but the appropriate change in the appearance of the indicator should not be taken as a guarantee of the sterility of the contents. Each package or item should be dated with the date of sterilisation to assist in correct stock rotation.

307. The outer surfaces of all packages of equipment, vessels, etc., which are introduced into the aseptic testing environment (including vessels of media and packages or containers of goods to be tested) should be free of contamination immediately prior to their introduction into the aseptic environment: they should be sterilised or disinfected by an appropriate method which does not prejudice the viability of micro-organisms which may be present in the preparations to be tested. A pass-through hatch (or transfer box) is considered part of the testing environment. If the packages are double-wrapped and sterilised the outer wrapping should be removed just prior to the introduction of the package into the testing environment.

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